Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection


The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.

Full Title of Study: “Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2020


  • Other: HBV infection history
    • HBV infection history or HBV carriers

Arms, Groups and Cohorts

  • all the antigen and antibody of HBV are negative
    • Hepatitis B Virus surface antigen (HBsAg), Hepatitis B Virus surface antibody (HBsAb), Hepatitis B Virus e antigen (HBeAg), Hepatitis B Virus e antibody (HBeAb), Hepatitis B Virus core antibody (HBcAb) are all negative.
  • HBV infection history
    • One or more of HBsAb,HBeAb, HBcAb are positive, while HBsAg and HBeAg are negative. If only HBsAb is positive, the history of HBV vaccination need to be excluded.
  • HBV carriers
    • One or two of HBsAg and HBeAg are positive, accompanied by any HBV antibody is positive or not.

Clinical Trial Outcome Measures

Primary Measures

  • changes of alanine transaminase (ALT, U/L)
    • Time Frame: one month, three months, six months
    • The peak increases of ALT from baseline to follow-up
  • number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
    • Time Frame: one month, three months, six months

Secondary Measures

  • number of participants with alanine transaminase (ALT) increasing over the ULN
    • Time Frame: one month, three months, six months

Participating in This Clinical Trial

Inclusion Criteria

  • patients with CHD receive long-term statin treatment Exclusion Criteria:

  • ALT is over ULN at baseline – infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus – triglyceride is over 4.5 mmol/L – decompensated liver cirrhosis (Child B or C) – active stage of HBV – infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease – congestive heart failure – malignant tumor – autoimmune disease – receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Affiliated Hospital with Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhijian Yang, Doctor, Study Chair, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
  • Overall Contact(s)
    • Zhijian Yang, Doctor, +83 13809030208,


Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. doi: 10.1161/01.CIR.0000131519.15067.1f.

Ekstedt M, Franzen LE, Mathiesen UL, Holmqvist M, Bodemar G, Kechagias S. Statins in non-alcoholic fatty liver disease and chronically elevated liver enzymes: a histopathological follow-up study. J Hepatol. 2007 Jul;47(1):135-41. doi: 10.1016/j.jhep.2007.02.013. Epub 2007 Mar 8.

Segarra-Newnham M, Parra D, Martin-Cooper EM. Effectiveness and hepatotoxicity of statins in men seropositive for hepatitis C virus. Pharmacotherapy. 2007 Jun;27(6):845-51. doi: 10.1592/phco.27.6.845.

Balmer ML, Dufour JF. Treatment of hypercholesterolemia in patients with primary biliary cirrhosis might be more beneficial than indicated. Swiss Med Wkly. 2008 Jul 26;138(29-30):415-9. doi: 10.4414/smw.2008.12311.

Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. doi: 10.1016/j.amjcard.2005.12.014. Epub 2006 Feb 3.

Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.

Lu J, Zhou Y, Lin X, Jiang Y, Tian R, Zhang Y, Wu J, Zhang F, Zhang Y, Wang Y, Bi S. General epidemiological parameters of viral hepatitis A, B, C, and E in six regions of China: a cross-sectional study in 2007. PLoS One. 2009 Dec 24;4(12):e8467. doi: 10.1371/journal.pone.0008467.

Citations Reporting on Results

Zhang Q, Yang Z. Can statins be used safely in coronary heart disease patients of hepatitis B virus carriers? Int J Cardiol. 2011 Jan 21;146(2):291. doi: 10.1016/j.ijcard.2010.10.087. Epub 2010 Dec 3. No abstract available.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.